AstraZeneca is testing Capivasertib + Palbociclib + Fulvestrant advanced breast cancer

AstraZeneca is testing Capivasertib + Palbociclib + Fulvestrant for HR+/HER2- Advanced Breast Cancer 


A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292).

This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with palbociclib and fulvestrant in participants with endocrine-resistant locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of palbociclib + fulvestrant are established, the dose and schedule for the triplet combination (capivasertib + palbociclib + fulvestrant) needs to be confirmed.

Therefore, the initial dose finding Phase Ib part of the study will confirm the recommended Phase III doses (RP3D) and schedule of administration of capivasertib and palbociclib for the triplet combination including fulvestrant which will then be used in the Phase III part of this study.

The researchers plan that April 30, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in January 15, 2027.

Among primary outcome measures are the Phase Ib: 2. The number of participants with treatment-related adverse events and Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.

For study sites, inclusion and exclusion criteria please check the page dedicated to this clinical trial:

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